510(k) K823622
K823622 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "INSULATED THERMOELASTOMER MITT". The FDA issued a decision of Substantially Equivalent on December 30, 1982. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1982
- Date Received
- December 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Heat, Moist
- Device Class
- Class I
- Regulation Number
- 890.5730
- Review Panel
- PM
- Submission Type